Margetuximab

BIOLOGICAL9 trials

Sponsors

MacroGenics, TerSera Therapeutics LLC, Zai Lab (Shanghai) Co., Ltd., Dana-Farber Cancer Institute, MedSIR

Conditions

Advanced Breast CancerAdvanced Solid TumorsBreast CancerBreast Cancer MetastaticCervical CancerCholangiocarcinomaGastric CancerGastroesophageal Junction Cancer

Phase 1

Safety Study of MGAH22 in HER2-positive Carcinomas

CompletedNCT01148849

MacroGenicsBreast Cancer, Gastric Cancer

Start: 2010-07-31End: 2022-06-14Updated: 2025-02-26

A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms

CompletedNCT03219268

MacroGenicsAdvanced Solid Tumors, Cervical Cancer, Cholangiocarcinoma +7

Start: 2017-08-18End: 2023-02-08Updated: 2023-12-21

Phase 2

Phase 2 Study of the Monoclonal Antibody MGAH22 (Margetuximab) in Patients With Relapsed or Refractory Advanced Breast Cancer

CompletedNCT01828021

MacroGenicsBreast Cancer

Start: 2013-03-31End: 2017-04-14Updated: 2025-03-13

Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

CompletedNCT04082364

MacroGenicsGastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer

Start: 2019-09-30End: 2025-03-25Updated: 2025-06-08

A Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ MBC

Zai Lab (Shanghai) Co., Ltd.Breast Cancer Metastatic

Start: 2020-01-13End: 2023-12-31Updated: 2023-08-22

MARGetuximab Or Trastuzumab (MARGOT)

Active, not recruitingNCT04425018

Dana-Farber Cancer InstituteBreast Cancer, HER2-positive Breast Cancer, Stage II Breast Cancer +1

Start: 2020-07-13End: 2027-07-01Updated: 2025-11-18

Margetuximab Plus Tucatinib and Capecitabine in HER2-positive Metastatic Breast Cancer

WithdrawnNCT05227131

MedSIRAdvanced Breast Cancer, HER2-positive Breast Cancer, Metastatic Breast Cancer

Start: 2022-05-15End: 2024-10-31Updated: 2022-07-11

Phase 3

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

CompletedNCT02492711

MacroGenicsHER-2 Positive Breast Cancer, Metastatic Neoplasm

Start: 2015-08-24End: 2022-06-14Updated: 2025-03-17

Unknown Phase

Margetuximab Expanded Access Program

TerSera Therapeutics LLCHER2-positive Breast Cancer, HER2-positive Carcinoma

Updated: 2025-02-14

Related Papers

The landscape of the intestinal microbiome amongst patients with newly diagnosed invasive breast cancer (BC) and ductal carcinoma in situ (DCIS).

Journal of Clinical Oncology2024-05-29

The PD-1- and LAG-3-targeting bispecific molecule tebotelimab in solid tumors and hematologic cancers: a phase 1 trial.

2023-10-1994 citations

Margetuximab: An active alternative for later‐line therapy in patients with HER2‐positive advanced breast cancer

MedComm2023-07-044 citations

Margetuximab Versus Trastuzumab in Patients With Previously Treated HER2-Positive Advanced Breast Cancer (SOPHIA): Final Overall Survival Results From a Randomized Phase 3 Trial

Journal of Clinical Oncology2022-11-0473 citations

Efficacy and safety of margetuximab plus chemotherapy vs. trastuzumab plus chemotherapy in Chinese patients with pretreated HER2-positive advanced metastatic breast cancer: results from a randomized, open-label, multicenter, phase II bridging study

Translational Breast Cancer Research2022-09-276 citations

Abstract PD8-01: Phase 3 SOPHIA study of margetuximab (M) + chemotherapy (CTX) vs trastuzumab (T) + CTX in patients (pts) with HER2+ metastatic breast cancer (MBC) after prior anti-HER2 therapies: Final overall survival (OS) analysis

Cancer Research2022-02-157 citations

Abstract PO-099: African American women with breast cancer have unique molecular features and reduced clinical trial enrollment

Cancer Epidemiology Biomarkers & Prevention2022-01-01

Abstract PS10-12: Integrated safety summary of single agent and combination margetuximab in phase 1, 2, and 3 studies of HER2-positive advanced cancers and metastatic breast cancer (MBC)

Cancer Research2021-02-153 citations

Abstract PS10-24: Infusion related reactions in the phase 3 SOPHIA trial of margetuximab + chemotherapy vs trastuzumab + chemotherapy in patients with pretreated HER2+ metastatic breast cancer

Cancer Research2021-02-15

Abstract PS9-11: Health-related quality of life for margetuximab + chemotherapy vs. trastuzumab + chemotherapy in the phase 3 SOPHIA trial of patients with pretreated HER2+ metastatic breast cancer

Cancer Research2021-02-15

Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer

JAMA Oncology2021-01-23336 citations

Margetuximab (M) combined with anti-PD-1 (retifanlimab) or anti-PD-1/LAG-3 (tebotelimab) +/- chemotherapy (CTX) in first-line therapy of advanced/metastatic HER2+ gastroesophageal junction (GEJ) or gastric cancer (GC).

Journal of Clinical Oncology2021-01-206 citations

MAHOGANY: Margetuximab Combination in HER2+ Unresectable/metastatic Gastric/gastroesophageal Junction Adenocarcinoma

Future Oncology2020-12-0296 citations

313 A phase 1 evaluation of tebotelimab, a bispecific PD-1 x LAG-3 DART® molecule, in combination with margetuximab in patients with advanced HER2+ neoplasms

Regular and Young Investigator Award Abstracts2020-11-016 citations

A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms.

Journal of Clinical Oncology2020-05-2048 citations

Immunohistochemistry analyses of LAG-3 expression across different tumor types and co-expression with PD-1.

Journal of Clinical Oncology2020-05-2014 citations

SOPHIA analysis by chemotherapy (Ctx) choice: A phase III (P3) study of margetuximab (M) + Ctx versus trastuzumab (T) + Ctx in patients (pts) with pretreated HER2+ metastatic (met) breast cancer (MBC).

Journal of Clinical Oncology2020-05-205 citations

Abstract GS1-02: Phase 3 SOPHIA study of margetuximab + chemotherapy vs trastuzumab + chemotherapy in patients with HER2+ metastatic breast cancer after prior anti-HER2 therapies: second interim overall survival analysis

Cancer Research2020-02-1535 citations

Abstract P1-18-04: Phase 3 SOPHIA study of margetuximab + chemotherapy vs trastuzumab + chemotherapy in patients with HER2+ metastatic breast cancer after prior anti-HER2 therapies: Infusion time substudy results

Cancer Research2020-02-15

Antibodies to watch in 2020.

2020-01-01328 citations

9 more papers not shown